
README FILE

Title:
Replication Data for Comparison of NADAL COVID IgG/IgM Rapid Test and DiaSorin Liaison SARS-CoV-2 S1/S2 IgG Assay Across Different Blood Sources and Substrates

Authors:
Harika Dasari, Claude Bourassa, Christian Renaud, Cécile Tremblay, Francine M. Ducharme

Corresponding Author:
Harika Dasari
University of Montreal
Email: harika.dasari@umontreal.ca

Date of Data Collection:
September 23, 2020 – July 6, 2021

Date of Deposit:
2025-05-15

Description of the Dataset:
This dataset supports the manuscript titled “Comparison of NADAL COVID IgG/IgM rapid test and DiaSorin Liaison SARS-CoV-2 S1/S2 IgG assay across different blood sources and substrates” published in Microbiology Spectrum (DOI: 10.1128/spectrum.03350-24).

It contains participant-level test data from two cross-sectional studies involving children and adults. The aim was to compare the diagnostic performance of the NADAL IgG/IgM rapid test against the DiaSorin Liaison IgG assay across different blood sources (venous vs capillary) and substrates (serum vs whole blood).

Files Included:
- NADAL_Database.xlsx
  Raw and cleaned dataset containing participant demographics, symptom scores, PCR and serology test results across different sources.
- Spectrum03350-24.pdf
  Published article outlining study design, methods, and results.

Variable Descriptions:
| Variable                        | Description                                                |
|---------------------------------|------------------------------------------------------------|
| Age                             | Participant’s age in years                                 |
| Gender                          | 1 = Male, 2 = Female                                       |
| COVID Status                    | 1 = Positive, 0 = Negative                                 |
| Vaccine_1, Vaccine_2            | 1 = Dose received, 0 = Not received                        |
| Diasorin Venous Serum (AU/mL)   | Quantitative IgG; in AU/mL                                 |
| Diasorin Venous Result          | 0 = Negative (<15AU/mL), 1 = Positive(≥15 AU/mL)           |
| Diasorin Capillary Serum(AU/mL) | Quantitative IgG; in AU/mL                                 |
| Diasorin Capillary Result       | 0 = Negative (<15AU/mL), 1 = Positive(≥15 AU/mL)           |
| Nadal Venous Serum              | 0 = Negative, 1 = IgG+, 2 = IgG+ & IgM+                    |                                      |
| Nadal Capillary Serum           | 0 = Negative, 1 = IgG+, 2 = IgG+ & IgM+                    |
| Nadal Capillary Blood           | 0 = Negative, 1 = IgG+, 2 = IgG+ & IgM+                    |
| Nadal Venous Blood              | 0 = Negative, 1 = IgG+, 2 = IgG+ & IgM+                    |

Methods Overview:
- Reference: DiaSorin Liaison SARS-CoV-2 S1/S2 IgG assay (venous serum, CLIA platform)
- Comparator: NADAL COVID-19 IgG/IgM lateral flow immunoassay (various blood sources)
- Analysis: Kappa, accuracy, sensitivity/specificity, violin plots, logistic regression

Ethical Approval:
- CHUSJ REB #2021–3067 and #MP-21–2021-3044
- Health Canada non-objection letters and Investigational Testing Authorization obtained

Citation:
Dasari H, Bourassa C, Renaud C, Tremblay C, Ducharme FM. Comparison of NADAL COVID IgG/IgM rapid test and DiaSorin Liaison SARS-CoV-2 S1/S2 IgG assay across different blood sources and substrates. Microbiology Spectrum. 2025. https://doi.org/10.1128/spectrum.03350-24
